New Interim Analysis From Observational Study Suggests That Delivery of Insulin Via Valeritas' V-Go Shows Promise in Improving Glycemic Control for Patients With Type 2 Diabetes

BRIDGEWATER, N.J., May 2, 2013 /PRNewswire/ -- Valeritas, makers of the V-Go® insulin delivery device, announced new interim analysis from an observational study today that suggest patients with Type 2 diabetes who switched to the V-Go insulin delivery device from their previous baseline treatment experienced potentially significant improved glycemic control and a reduction in total daily insulin dose. The interim results, part of a planned interim analysis performed as part of a long-term, prospective, observational study, were presented at the American Association of Clinical Endocrinologists (AACE) 22nd annual scientific and clinical congress.1

V-Go is a simple, fully-disposable device that delivers a continuous basal rate of insulin for 24 hours with on-demand mealtime dosing. It is designed to be easier to use and assist with blood glucose control in adult patients who require insulin.

"This observational study enables us to obtain data about the actual clinical benefit of the V-Go when used as directed by practicing physicians in a real-world setting," said Dr. Cheryl Rosenfeld, primary study investigator affiliated with North Jersey Endocrine Consultants. "These interim results are very promising, suggesting improved glycemic control, a reduction in total daily insulin dose with a nominal change in weight in patients switching to the V-Go."

The SIMPLE study, "Effectiveness of V-Go for Patients with Diabetes in a Real-world Setting: A Long-term, Prospective, Observational Registry," compared the changes in baseline and endpoint A1C measures and observed glycemic control, insulin dose requirements and other parameters. Patients with Type 2 diabetes and a baseline A1C greater than 7 percent were enrolled. Study participants were then switched from one of five baseline treatments to the V-Go for their basal and mealtime insulin delivery.1

The primary objective of the observational study was to compare change of average glycemic control as measured by A1C from baseline to the end of V-Go use for the whole cohort as well as each of the categories of baseline treatment. Patients in the study were followed on their current therapy for up to 6 weeks before starting the V-Go insulin delivery device.The study, observational in nature, has no mandated or forced titration instructions to guide insulin therapy with the exception of starting doses for V-Go basal rate options.1

The interim analysis of the observational study suggests that 47 patients had continuous V-Go use for a minimum of 3 months. Most of the patients in the study were men with an average age of 60 having diabetes for 13 years. At the time of this interim analysis, A1C levels for the study participants reduced from 9.0 percent to 8.6 percent during the 4 to 6 week run-in phase. After the run-in period and starting the V-Go, the interim results suggest that patient A1C levels further improved with a mean change from 8.6 percent to 7.8 percent; P<0.0001 from month 0 to month 3. Five patients reported adverse events probably related to V-Go (primarily rash or skin irritation). Six patients reported hypoglycemia <70 mg/dL. There was no significant change in weight. Additionally, total daily insulin dose was reduced by 19 percent (12.5 units) on average.1

About Diabetes

In order to fuel the human body's cells with glucose, or sugar, insulin is required. While the body continuously produces insulin, people with Type 2 diabetes, the most common form of diabetes, either do not produce enough insulin, or their bodies cannot use the insulin adequately. When there is not enough, or insulin is not used properly, glucose builds up in the blood instead of going into the body's cells. If not controlled properly, diabetes can increase the risk of heart disease, blindness, amputations, stroke, and high blood pressure.

The number of patients diagnosed with diabetes in the United States is alarming and continues to grow. According to the American Diabetes Association, nearly 26 million people in the United States have diabetes,2 with approximately 4.8 million depending on daily insulin injections to help them control and manage their diabetes.3 However, more than half of insulin users do not achieve their recommended target glucose levels for various reasons, including injection pain, or the embarrassment of injecting medication in public.

About the V-Go® Disposable Insulin Delivery Device

The V-Go® is a simple, fully disposable device for the delivery of basal-bolus insulin therapy in adults with Type 2 diabetes. The V-Go provides a continuous preset basal rate of insulin and allows for on-demand bolus dosing around mealtimes, thereby providing an alternative to taking multiple daily insulin injections.

The V-Go is small, lightweight and worn under the patients clothing. It measures just 2.4 x 1.3 x 0.5 inches and weighs approximately 1 ounce when filled with insulin. Patients apply a new V-Go to the skin daily for one 24-hour period. The V-Go is not electronic, making it easy to operate and use.

Important Risk Information: If regular adjustments or modifications to the basal rate of insulin are required in a 24-hour period, or if the amount of insulin used at meals requires adjustments of less than 2-Unit increments, use of the V-Go Disposable Insulin Delivery Device may result in hypoglycemia. The following conditions may occur during insulin therapy with the V-Go: hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose). Other adverse reactions associated with V-Go use include skin irritation from the adhesive pad or infections at the infusion site. The V-Go should be removed before any magnetic resonance imaging (MRI) testing.

About Valeritas, Inc.

Valeritas is committed to developing and commercializing innovative treatment solutions that contribute to clinical and humanistic outcomes for patients, with an initial focus on the treatment of Type 2 diabetes. Valeritas' portfolio is headlined by the V-Go® disposable insulin delivery device, which is being commercialized and reimbursed in a specialty pharmaceutical model and is distributed through retail pharmacy.

V-Go meets an adult Type 2 diabetes patient's insulin needs by providing a treatment that is simple, convenient and easy to use. V-Go mimics the insulin pattern of the body (when used according to the Instructions for Patient Use) by providing a continuous preset basal rate of insulin over 24 hours and on-demand bolus dosing at mealtimes.

Valeritas' development portfolio also includes the h-Patch technology for the delivery of other compounds beyond insulin, the Mini-Ject Pre-Filled Needle-Free Delivery System, and the Micro-Trans Microneedle Transdermal Delivery Patch. These technologies, not commercially available, when combined with certain compounds, are designed to provide unique products that allow precise dosing in previously difficult to treat conditions.

In March 2011, Valeritas received EU CE Mark approval for V-Go. In November 2012, Valeritas was named Life Science Company of the year by the New Jersey Technology Council for its targeted mission and focus on the development of technology to improve the lives of people with Type 2 diabetes. Its Executive Management Team was further recognized for the ability to effectively develop and commercialize devices at high volumes. In addition, Valeritas received the 2012 Scrip Financing of the Year award for raising $150 million in Series C financing in September 2011.

Headquartered in Bridgewater, New Jersey, Valeritas operates its R&D and manufacturing in a state-of-the-art facility in Shrewsbury, Massachusetts. For more information, visit www.valeritas.com

Disclosure Notice:

This press release contains forward-looking statements, which may include statements about regulatory submissions and the timing and potential for FDA review and approval of such submissions, the efficacy and safety of Valeritas' product candidates, market opportunities for V-Go® and the clinical importance of V-Go, as well as any other financial projections. Such forward-looking statements may be identified by, among other things, the use of forward-looking terminology such as "believes", "expects", "may", "should" or "anticipates" or the negative thereof or other variations thereon or comparable terminology, or by discussions of strategy that involve risks and uncertainties. The forward-looking statements contained in this press release are based on our current expectations, and those made at other times will be based on our expectations when the statements are made. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals. The forward looking statements contained herein are made only as of the date of this press release and Valeritas undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

References

1. Rosenfeld, C., and Grunberger, G. Effectiveness of V-Go for Patients with Diabetes in a Real-World Setting: A Long-Term, Prospective, Observational Registry (SIMPLE). Date to be presented at the American Association of Clinical Endocrinologists Annual Meeting. May 1 5, 2013. Phoenix, Arizona.